Kornimate/medical-research-clean huggingface dataset:
patient centered methods to collect sexual orientation and gender identity status in the ed

Conditions: Homosexuality; Gender Identity

Summary: this trial is the final phase of a three phase pcori-funded study to develop and test patient-centered approaches to collect sexual orientation and gender identity (so/gi) information in the ed. from the results of phase 1 qualitative interviews and national quantitative survey and phase 2 delphi rounds with the stakeholder advisory board, we have determined two methods of collection favored by patients and providers to implement in the trial. the first method, nurse verbal collection, is in alignment with partners recommended clinical practice and is therefore a quality improvement (qi) evaluation. the second method, non-verbal registrar form collection with nurse verbal confirmation, is a research intervention to evaluate and compare a new patient-centered approach to so/gi collection. to compare the patient-centeredness of the two different approaches, satisfaction surveys will be administered to ed patients and staff members involved in collection. in summary, the study design (1) evaluates recommended current practice (qi), (2) evaluates a quality improvement project to increase recommended current practice, and (3) evaluates a new method of collecting so/gi (research intervention).


Eligibility criteria:
inclusion criteria: * adult ed patients who are cognitively and physically capable of informed consent * adult ed nurses and registrars who are cognitively and physically capable of informed consent exclusion criteria: * children * any person not cognitively and physically capable of informed consent
skeletal muscle myokine response to acute eccentric exercise

Conditions: Skeletal Muscle

Summary: the purpose of this study is to evaluate the acute local skeletal muscle inflammatory response to thigh muscle (quadriceps) eccentric muscle actions. eccentric muscle actions occur when the muscle is lengthening as it contracts. this is a pilot project to assess the degree of inflammatory biomarkers, called myokines, that are released locally in skeletal muscle tissue after an acute bout of resistance-exercise using a resistance-exercise machine called an isokinetic dynamometer.

the intervention will involve one session of maximal eccentric exercise of the knee extensor muscles (quadriceps) of the right leg. during the 24-hour period preceding the intervention, participants will be asked to refrain from any for of moderate-vigorous physical activity or exercise. participants will perform 30 sets of 10 repetitions of maximal isokinetic eccentric knee extensions at 60 degrees/second with 1-minute of rest between each set. before completing the exercise bout, each participant will be asked to remain in a seated position (resting) for 30-minutes and then provide a skeletal muscle biopsy using the modified bergstrom with suction muscle biopsy technique from the vastus lateralis on the right leg. this will be done for the baseline assessment of 5 myokines including apelin, fibroblast growth factor-21, irisin, interleukin-6, and interleukin-15. then the participants will complete the exercise bout as described above. they will then rest quietly in the laboratory for 3-hours and wait for the second skeletal muscle biopsy to be taken following this 3-hour wait.

Eligibility criteria:
inclusion criteria: * 18-35 years old * healthy * recreationally active (\>/= 150 minutes of moderate to vigorous physical activity per week for at least the past three months) exclusion criteria: * "yes" answer to the get active questionnaire which screens for health conditions that may affect exercise ability
eaa/therapy for treating children with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the aim of this study is 1) to investigate clinical effects of equine-assisted activities and therapy (eaa/t) for treating attention-deficit/hyperactivity disorder (adhd) and 2) to compare the clinical effect of eaa/t and drug therapy in children 6-13-years-of-age. this study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of eaa/t. forty six subjects will be enrolled and various clinical tests will be administered at baseline and after eaa/t or drug therapy.

this study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of eaa/t. forty six subjects will be aasigned 12 weeks of eaa/t or drug therapy, and various clinical tests will be administered at baseline and after eaa/t or drug therapy. assessments included the investigator-administered adhd-rating scale (ars-i), clinical global impressions - severity scale (cgi-s), clinical global impressions - improvement scale (cgi-i), gordon diagnostic system (gds), korea-child behavior checklist (k-cbcl), self-esteem scale (ses), bruininks-oseretsky test of motor proficiency, second edition (bot-2), and quantitative electroencephalography (qeeg) or functional magnetic resonance imaging(fmri) study. this study has two objectives. the first objective is to investigate clinical effects of equine-assisted activities and therapy (eaa/t) for treating attention-deficit/hyperactivity disorder (adhd). for this one, we determine the treatment response rate as the primary outcome measure. the treatment response is defined as ≥ 30% decline than baseline in the ars-i score or in cgi-i scores of 1 or 2 to endpoint. the second objective is to compare the clinical effect of eaa/t and drug therapy in children with adhd.

Eligibility criteria:
inclusion criteria: * a diagnosis of adhd according to diagnostic and statistical manual-iv-text version(dsm-iv-tr) and korean kiddie-schedule for affective disorders and schizophrenia-present and life¬time version (k-sads-pl) exclusion criteria: * (1) a learning disorder or an intelligence quotient (iq) measured by the korean wechsler intelligence scale for children-iv (k-wisc-iv) \< 70, (2) significant medical condition, schizophrenia or other psychotic disorder, bipolar disorder, a history of alcohol or drug dependence, neurologic disorders, epilepsy, and organic mental disorders; (3) a major depressive disorder that required pharmacotherapy; (4) significant suicidal ideation; (5) a tourette's disorder or obsessive-compulsive disorder that required pharmacotherapy; (6) use of methylphenidate or atomoxetine within 90 days of baseline
uhcds a-tdcs combined with therapeutic exercise in fibromyalgia patients

Conditions: Fibromyalgia

Summary: the purpose of this study is to assess the effects on fatigue and sleep of unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise in fibromyalgia patients.

fibromyalgia (fm) is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated. perhaps this is why its therapeutic approach is refractory to current treatments. apart from the widespread chronic pain characteristic of this syndrome, fatigue is a very disabling symptom in this pathology. it is a complicated, multifactorial, disconcerting and very persistent symptom that is highly frequent in fm. a vast majority of the published studies have focused the symptoms studied in fm on pain, while fatigue and sleep disturbances, despite not being minor symptoms, have not received the same attention. neuromodulation treatments with transcranial direct current stimulation (tdcs) have been shown to induce significant analgesia in fm through modification of sensory processing of pain by thalamic inhibitory circuits and improvement of sleep architecture. on the other hand, therapeutic exercise (te) programs based on aerobic work and global muscle strengthening have been shown to have a beneficial effect in reducing the pain and severity of fm. none of the four studies conducted so far combining tdcs and te in fibromyalgia have evaluated the effect on fatigue or sleep. currently, various studies conclude that unihemispheric concurrent dual-site anodal transcranial direct current stimulation (uhcds a-tdcs) on the dorsolateral prefrontal cortex (dlpfc) and m1 produces a 50% greater modulation of corticospinal excitability. to date, no rct has studied its effect in subjects with fm. the present study aims to investigate the effect of uhcds a-tdcs combined with te on fatigue and sleep quality in subjects with fm.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years. * fulfilled the 2010 american colleague of rheumatology criteria for fibromyalgia. * able to participated in a therapeutic exercise program. * understanding of spoken and written spanish. exclusion criteria: * pregnancy or breastfeeding. * metallic implants in the head. * tumor, trauma or surgery in the brain. * epilepsy or stroke. * history of substance abuse in the last 6 months. * use of carbamazepine in the last 6 months. * diagnosed psychiatric pathology. * rheumatic pathology not medically controlled. * coexisting autoimmune pathology. * chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).

Keywords: neuromodulation therapeutic exercise fatigue sleep
the early and late contribution of fasting and postprandial triglycerides on newborn subcutaneous and intrahepatic fat in pregnancy

Conditions: Pregnancy

Summary: this study plans to learn more about how triglyceride levels in pregnancy affect newborn fat mass. obesity in pregnancy, in the absence of gestational diabetes, is now the most common cause of large-for-gestational-age infants and increased newborn fat mass. previous data supports the idea that maternal triglycerides, not glucose, are the strongest predictor of both total newborn fat mass and liver fat. in this study, mothers will monitor triglyceride and glucose levels at specific points in pregnancy using point-of-care meters at home. two weeks after birth, infants will have total fat measured by air-displacement plethysmography (peapod) and liver fat measures by magnetic resonance spectroscopy (mrs). the central hypothesis is that in obesity, fasting triglycerides and postprandial triglycerides will predict newborn fat mass in a free-living environment.


Eligibility criteria:
inclusion criteria: * pregnant women less than 16 weeks gestational age * between the ages of 21-39 years * pre-pregnancy bmi 28-39 kg/m2 exclusion criteria * pre-gestational diabetes or prediabetes * history of gestational diabetes * history of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension \<34wks * tobacco or illicit substance use * chronic steroid use

Keywords: triglycerides glucose adiposity air displacement plethysmography continuous glucose monitoring
real-world treatment study of koselugo (selumetinib)

Conditions: Neurofibromatosis 1; Neurofibroma, Plexiform

Summary: as part of a post-approval commitment, the korean health authority requests a study to characterize safety and effectiveness in patients treated with koselugo (selumetinib), an oral selective inhibitor of mapk kinase (mek) 1 and 2, by physicians in routine clinical practice settings. this study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of koselugo under conditions of routine daily medical practice in korea. this study will provide information on the korean patient population that is treated with the study drug.


Eligibility criteria:
inclusion criteria: 1. patients treated with koselugo (selumetinib) under the approved label in south korea 2. provision of signed and dated written informed consent by the patient or legally acceptable representative exclusion criteria: 1. patients treated with koselugo (selumetinib) under the approved label in south korea 2. provision of signed and dated written informed consent by the patient or legally acceptable representative
clinical study of bone graft substitutes in orthopaedic and spinal applications.

Conditions: Bone Deformity

Summary: this is an observational, prospective, non-randomised, multi-centred post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.


Eligibility criteria:
inclusion criteria: long bone and extremity indications: patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities. spine indication: patients with degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies and where conservative treatment has been unsuccessful. patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center; exclusion criteria: patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. each instance should be brought to the attention of the sponsor to determine eligibility. women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); the subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
effectiveness of biofreeze® on shoulder pain and in-office exercise performance

Conditions: Shoulder Pain

Summary: biofreeze® is a topical analgesic, frequently used in the office or given to a patient for home use as a way to mitigate pain during the course of treatment. rehabilitative exercises are considered an important component of care for shoulder pain patients, although pain can be a limiting factor in the advancement of rehabilitation. the purpose of this study is to evaluate the addition of biofreeze® to an in-office group of shoulder pain patients to determine its impact on pain reduction. methods: patients 18-64 years old with mechanical shoulder pain who are candidates for standard shoulder therapy will be randomized into two groups (n=20). the control group (n=10) will receive standard shoulder therapy alone while the intervention group (n=10) will receive standard shoulder therapy plus biofreeze® just prior to initiating the in-office exercise program. values of pain (nprs) and disability (ases) will be recorded at baseline, 2 weeks, and 4 weeks. hypotheses will be addressed by repeated measures anovas within and between group, time, and interaction main effects. clinical relevance: progression of therapeutic exercises can be limited by pain and the associated disability. the ability to decrease shoulder pain and disability with a topical analgesic will allow health care professionals to advance patients through a therapeutic exercise program without the restriction of pain. in turn, patients will correct the underlying condition of their shoulder pain at a faster rate.


Eligibility criteria:
inclusion criteria: * 18-64 years old * mechanical shoulder pain * candidates for conservative care exclusion criteria: * pregnancy * radicular symptoms * not a candidate for conservative care * history of recent shoulder surgery
etms for veterans and first responders with ptsd

Conditions: Post Traumatic Stress Disorder

Summary: a battery of physiological and behavioral data will be collected before and after application of etms. participants will be veterans or first responders diagnosed with ptsd. study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.

veterans and first responders diagnosed with ptsd will be studied to evaluate safety and efficacy of an eeg personalized tms paradigm. all participants will undergo 2 days of extensive testing prior to etms application and 2 days of testing after. testing will include mri, opm, eeg, behavioral tasks, questionnaires, and an eeg sleep study.

Eligibility criteria:
inclusion criteria: * veteran or first responder * diagnosed with post-traumatic stress disorder with pcl-5 cutoff of 31 or above exclusion criteria: * claustrophobia * contraindications to mri * pregnant * uncontrolled medical, psychological, or neurological conditions * unable to calculate eeg alpha frequency * history of ect or rtms * history of intracranial lesion or increased intracranial pressure * history of stroke * history of other neurologic conditions * family history of epilepsy * personal history of epilepsy * certain medications
neural mechanism of cerebrocardiac syndrome following traumatic brain injury

Conditions: Traumatic Brain Injury; Cerebrocardiac Syndrome

Summary: cerebrocardiac syndrome (ccs), including myocardial injury, arrhythmia or heart failure is one of serious complications of traumatic brain injury (tbi), mostly occurs within seven days after tbi, which directly aggravates the brain damage and affects the prognosis of tbi patients. accumulative evidences suggest that autonomic nervous system disorder is a key initiation point for ccs, but how tbi affects the specific action patterns is not yet clear. therefore, elucidating the neural mechanisms of tbi-induced ccs, maintaining the central sympathetic-parasympathetic balance through novel interventions such as noninvasive brain stimulation, may fundamentally block the downstream peripheral mechanism, thus achieving effective prevention and treatment for ccs. based on the current emerging research in brain connectomics and lesion-symptom mapping, we speculate that cerebral contusions can cause structural or functional disconnection of key nodes in the central autonomic nervous system regulatory network, thereby mediating the occurrence of tbi-induced ccs. in this study, magnetic resonance imaging (mri) or functional mri (fmri) examinations were performed in patients with mild or moderate tbi with aim to explore the association between structural and functional disconnection caused by cerebral contusion and tbi-induced ccs, and to screen out the neural anatomical structures to predict ccs following tbi, providing therapy targets for prevention and treatment of ccs.


Eligibility criteria:
inclusion criteria: * patients with isolated closed head trauma * age 18-80 years old * admitted to hospital within 24 hours of injury * mild or moderate tbi (glasgow coma scale score of 9-15) * signed consent form exclusion criteria: * severe tbi (glasgow coma scale score of 3-8) * a history of stroke, tbi, intracranial tumor or surgery in the past 1 year * a history of coronary heart disease, structural heart disease and other primary heart diseases or suspected cardiac symptoms prior to injury * causes of abnormal cardiac biomarkers such as renal insufficiency, severe anemia, sepsis, cardiotoxic drugs and so on * not suitable for mri examinations, such as pregnant women and those with metal implants in the body * undergo surgery prior to mri examinations or cardiac testing

Keywords: traumatic brain injury cerebrocardiac syndrome brain connectomics
sensory responses to dorsal root stimulation

Conditions: Amputation; Sensation, Phantom

Summary: the goal of this project is to characterize the types of sensations that can be evoked via electrical stimulation of the spinal cord and spinal nerves. patients will be recruited from a local pain clinic, each with a spinal cord stimulation device implanted, to participate in experiments to explore the ability to modulate and control the modality, intensity, focality, and location of the sensations evoked by stimulation through the spinal cord stimulator leads. investigators will connect spinal cord stimulator leads to a custom stimulator system and will ask subjects to report the types of sensations felt. invesigators will also perform detailed psychophysical metrics to examine participants' ability to discriminate sensations.

for this study, investigators aim to determine whether drg and spinal root stimulation might be viable techniques for restoring feedback. investigators will focus on patients undergoing temporary percutaneous trials of drg or lateral spinal cord stimulation with leads manufactured by either boston scientific (under pma p030017) or st. jude (under pma p150004), which have fda premarket approval for the management of chronic pain in the trunk and lower limbs. in this early experiment, investigators will not focus on individuals with limb loss, but rather will include patients already undergoing a percutaneous trial of drg or spinal root stimulation to treat pain. investigators will characterize the location, modality, and intensity of sensations evoked in the hands or feet with stimulation delivered by an external stimulator.

Eligibility criteria:
inclusion criteria: 1. subjects must be between the ages of 18 and 70 years old. 2. subjects must be undergoing an epidural spinal cord implanted electrode array clinical trial with dr. helm for the management of pain. 3. persons must understand the consent and the procedures. exclusion criteria: 1. persons with open wounds; 2. persons with implanted metal rods in the spine or limbs; 3. persons with defibrillator or pacemaker; 4. persons with permanent skin metal tags or decorations.

Keywords: spinal cord stimulation dorsal root ganglia stimulation sensation amputation pain
ttfields in general routine clinical care in patients with pleural mesothelioma study

Conditions: Pleural Mesothelioma

Summary: the purpose of this post-authorisation medical device study is to obtain real life data on the use of tumor treating fields (ttfields) in patients with pleural mesothelioma in routine clinical care. patients with pleural mesothelioma and clinical indication for ttfields treatment will be enrolled in the study after signing informed consent to use their data and process it centrally for research purposes. the clinical indication for ttfields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * histologically confirmed pleural mesothelioma without any option of curative resection * planned treatment with novottf-200t system according to ifu and medical guidelines * life expectancy more than 3 months at day of enrollment * signed informed consent for use and processing of data exclusion criteria: • previous treatment with novottf-200t for more than 1 week at day of enrollment

Keywords: pleural mesothelioma ttfields